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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: terlipressin
Trade Name: Terlivaz
Date Designated: 10/29/2004
Orphan Designation: Treatment of Hepatorenal Syndrome
Orphan Designation Status: Designated/Approved
Mallinckrodt Pharmaceuticals Ireland Ltd
College Business & Technology Park
Cruiserath Road
Blanchardstown, Dublin, Ireland D15 TX2V
Ireland

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: terlipressin
Trade Name: Terlivaz
Marketing Approval Date: 09/14/2022
Approved Labeled Indication: To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
Exclusivity End Date: 09/14/2029 
Exclusivity Protected Indication* :  To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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